Far-Forward Burn Treatment

Purpose

This solicitation, issued by MTEC, represents a Request for Project Proposals (RPP) for MTEC support of the U.S. Department of Defense (DoD) U.S. Army Medical Materiel Development Activity (USAMMDA). Proposals selected for award as a result of this RPP will be awarded under the authority of 10 U.S.C. § 2371b. The award(s) will be managed by the Warfighter Expeditionary Medicine and Treatment (W-EMT) Project Management Office (PMO), specifically by the chairperson of the Burn Treatment Skin Repair (BTSR) Integrated Product Team (IPT). The IPT will provide consultative input into the project as needed in preparation for their annual in-progress reviews with the Milestone Decision Authority, as well as interim reviews if needed more frequently.

This RPP is focused on the development of treatments for severe burn injuries in a far-forward, austere environment to address the harmful sequelae of the burn injury during prolonged care, which could extend for several weeks post-injury. This RPP addresses the following four capability gaps: burn conversion prevention, infection prevention, non-surgical debridement, and temporizing cover.

Scope of Work

Scope of Work of Base Period of Performace (PoP1) (up to 24 months):

The initial base PoP1 (which is limited to a period not to exceed 24 months) should be focused on tasks relevant to advance the prototype to the next Technology Readiness Level (TRL). Project scope should be proposed based on the prototype’s maturity at the time of submission. The work in the base PoP1 could include, but is not limited to:

• Prototype refinement/maturation progressing toward clinical product/
• Clinical feasibility studies (as needed) to support regulatory approval/clearance.
• Clinical pivotal studies (as needed) to support regulatory approval/clearance.
• Stability and shelf-life studies.
• Prototype delivery for military-relevant testing:
  • Testing of prototypes at U.S. Army Institute of Surgical Research (USAISR).
  • Testing of prototypes at Army Medical Department (AMEDD).
  • Product demonstrations.
• Establishment of Good Manufacturing Practice (GMP) manufacturing for clinical trials and for market release.
• Initial production runs, first article testing, etc.
• Low-rate initial product runs to reach Full Operating Capability (FOC).
• Draft product support documentation (e.g., training guides, product inserts, etc.).
• Development of a business and/or commercialization plan for market release.

Go/No-Go Decision Point for Downselect: Prior to the end of the base PoP1 (tentatively projected to occur 20 months into PoP1), the Government will conduct an in-process review (IPR), which the Awardees will attend and participate in, to assess the work completed for each PoP1 Awardee. The IPR will be either a virtual or an in-person meeting at USAMRDC at Fort Detrick, MD. Following the IPR, the Government intends to down-select Awardees to a smaller number for continuation of funding for the conduct of follow-on work representing PoP2 or the subsequent PoP of the prototype project. This down-select represents the Go/No-Go decision point between PoP1 (base) and PoP2 (subsequent).

In preparation for the IPR, all awardees shall submit a deliverable to the Government. Specifically, each Awardee shall submit full details of the tasks proposed for the subsequent PoP2 phase in separate technical and cost volumes. The exact due date for this deliverable is to be determined (anticipated on or about two weeks prior to the date of the IPR). This deliverable will be reviewed and evaluated as part of the Go/No-Go decision point during which time the Government will make award recommendations for the subsequent PoP2 selections.

All Offerors responding to this RPP shall account for the IPR requirement and associated deliverable requirement by identifying these as a milestone(s) in the Stage 1 (White Paper) proposal submission (under the “Anticipated Outcomes” section of the White Paper and elsewhere, as appropriate).

Potential for Follow-on Work: Potential follow-on work to include PoP2 (but may also include additional, non-competitive tasks negotiated after OTA award) may be awarded based on the advancement in prototype maturity during the base PoP1. Potential follow-on work may include tasks related to advancement of prototype maturity and/or to expand the use or utility of the prototype.

Points of Contact

For inquiries, please direct your correspondence to Biomedical Research Associate Chuck Hutti, Ph.D. at Chuck.Hutti@ati.org.